Like Apollo Creed in “Rocky,” the FDA came out full of confidence in April and got decked in a Florida federal courtroom.

Well, not completely decked. But the FDA lost two out of three civil violation claims against orthopedic device maker Endotec Inc. and two officers. The FDA alleged Endotec was selling ankle, jaw and knee devices outside the scope of clinical trials and was advertising unapproved devices. After issuing warning letters, the FDA sued Endotec in federal court in Orlando, seeking a permanent injunction and disgorgement of profits.

Typically, these types of enforcement actions — if they even make it to court — are pre-packaged affairs: the FDA simultaneously files a complaint and a consent decree with a monetary penalty. One claim against Endotec apparently went into the FDA dispute regulation process, but the Little Ortho Company That Could went to the mat on three claims.

The FDA seemed to have a strong case, at least in regards to the ankle device: Endotec was approved to enroll 109 patients in a clinical trial but its database listed about 4,000 units. When the dust settled, Senior Judge G. Kendall Sharp found for Endotec on the ankle and jaw devices and for the FDA on the knee device. The judge ruled the ankle and jaw devices were custom-made medical devices exempt from FDA regulation.

While Judge Sharp admonished Endotec against advertising its ankle devices and to stick to clinical trial requirements, he twice took the FDA to task for “stymieing progress and technological advancement.” He urged the FDA to get Congress to “speed up procedures.”

Endotec has an ax to grind with the FDA and Judge Sharp put an edge on it (sorry, couldn’t resist). On its Web site, Endotec rails against the FDA for requiring lengthy premarket approval studies for mobile bearing ankle devices instead of the easier 510(k) process. It says the FDA has sat on its citizen’s petition for five years, while the types of devices it wants to sell are available abroad.

What makes this David v. Goliath case noteworthy is that Endotec isn’t one of the orthopedic “biggies,” but it still took on the FDA and won. I’m not sure if it’s there as an example of heavy handed government regulation or if it’s there as a taunt, but Endotec’s Web site includes a 2007 Justice Department press release about deferred prosecution agreements involving some orthopedic biggies who submitted under the threat of criminal action: Zimmer, DePuy, Smith & Nephew, Biomet and Stryker.

And while you can tick off the names of the national law firms that represent the orthopedic varsity team, Endotec’s counsel, Vello Veski of the Law Offices of Vello Veski in Palm City, Fla., isn’t among them. His e-mail address is via Hotmail. In fact, he’s never been mentioned in Mealey’s Emerging Drugs & Devices until now. Maybe we’ll see his name more often. Someone put him on an FDLI or AEI agenda!

But what’s also striking about the Endotec case is that the outcome gives pause to the notion that the FDA has legal muscle to back up its regulatory mandate. In a time when critics are saying that the FDA isn’t the enforcer it’s said to be, it turns out that in this case, it isn’t.